BioSpace News Archive

Business

ESSA Appoints Otello Stampacchia, PH.D., of Omega Funds to Board of Directors

Mr. Stampacchia was appointed pursuant to the terms of a nomination rights agreement between the Company and Omega Fund Management, LLC.

October 22, 2018
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6 min read
Drug Development

AVEO Oncology and EUSA Pharma Announce Updated Interim Results from Phase 2 Portion of the TiNivo Study in Renal Cell Carcinoma

Tivozanib-Nivolumab Combination Continues to Demonstrate Favorable Efficacy and Safety

October 22, 2018
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9 min read
Drug Development

Investigational Subcutaneous Formulation of Vedolizumab Achieves and Maintains Clinical Remission and Mucosal Healing at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis

Additional subgroup analysis shows subcutaneous formulation of vedolizumab achieves significantly higher clinical remission rates to placebo in anti-TNFα-naïve patients

October 22, 2018
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13 min read
Pharm Country

IAVI and Serum Institute of India to Develop and Manufacture Globally Affordable and Accessible Antibody Products for HIV

Collaboration to develop optimal combination of HIV-specific antibodies and ensure that cost is not a barrier to access

October 22, 2018
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8 min read
FDA

Biohaven Receives Authorization to Proceed from FDA and Doses First Subject with BHV-3500, Third-Generation, Small Molecule CGRP-Receptor Antagonist

BHV-3500 is the first small molecule calcitonin gene-related peptide (CGRP) receptor antagonist to be administered in an intranasal (IN) formulation in human testing

October 22, 2018
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7 min read
Drug Development

Genentech’s Tecentriq Plus Chemotherapy (Carboplatin and Abraxane) as an Initial Treatment Helped People With Advanced Non-Squamous Non-Small Cell Lung Cancer Live Significantly Longer Compared to Chemotherapy Alone

The Phase III IMpower130 study investigating the Tecentriq plus chemotherapy combination demonstrated a significant overall survival (OS) and progression-free survival (PFS) benefit

October 22, 2018
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12 min read
Outline of New ESMO Guidelines Indicates Inclusion of FOTIVDA®▼ (Tivozanib) for Patients with Advanced Renal Cell Carcinoma

EUSA Pharma (EUSA) welcomes the news that FOTIVDA®▼ (tivozanib) is expected to be included in the upcoming European Society of Medical Oncology (ESMO) clinical practice guidelines for advanced renal cell carcinoma (aRCC), anticipated to be published at the end of this year.

October 22, 2018
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6 min read
Drug Development

Mirati Therapeutics Presents Updated Positive Clinical Data From Sitravatinib Immuno-Oncology Combination Trial At ESMO 2018 Congress And Announces FDA Guidance For Registration Trial

Updated analysis from ongoing Phase 2 trial of sitravatinib in combination with nivolumab demonstrated significant clinical activity in patients with checkpoint refractory non-small cell lung cancer (NSCLC)

October 22, 2018
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8 min read
Policy

Sinovac Granted Interim Injunctive Relief Regarding Filings Bearing a Falsified Company Seal and Forged Board Member Signatures

Senior management of Sinovac Biotech Ltd. and the lawful directors of Sinovac Hong Kong (“Lawful Directors”), Mr. Yin Weidong and Ms. Wang Nan, have been granted interim injunctive relief against Mr. Li Pengfei (“Mr. Li”) and Mr. Cao Jianzeng (“Mr. Cao”) by the High Court of the Hong Kong Special Administrative Region

October 22, 2018
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4 min read
Drug Development

Medicenna Presented Insights from the Phase 2b Clinical Trial of MDNA55 at the European Society for Medical Oncology 2018 Congress

Dr. Martin Bexon, Head of Clinical Development at Medicenna, presented results outlining the patterns of responses seen in the MDNA55 Phase 2b clinical trial in patients treated at low doses implemented during the first half of the study.

October 22, 2018
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5 min read